Tech Dots - Adhesive and conductive gel
K-Number: K190050 · 2019-07-19
ApplicantSpes Medica Srl
Decision Date2019-07-19
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Tech Dots - Adhesive and conductive gel is a medical device manufactured by Spes Medica Srl. It received FDA 510(k) clearance on 2019-07-19 under approval number K190050. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Tech Dots - Adhesive and conductive gel?
Tech Dots - Adhesive and conductive gel is a medical device that received FDA 510(k) clearance on 2019-07-19. It is manufactured by Spes Medica Srl. The 510(k) number is K190050.
When was Tech Dots - Adhesive and conductive gel approved by the FDA?
Tech Dots - Adhesive and conductive gel received FDA 510(k) clearance on 2019-07-19, under approval number K190050.
What company makes Tech Dots - Adhesive and conductive gel?
Tech Dots - Adhesive and conductive gel is manufactured by Spes Medica Srl.
What is the FDA product code for Tech Dots - Adhesive and conductive gel?
The FDA product code for Tech Dots - Adhesive and conductive gel is GYB.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.